Table 2.

Meta-analysis of Prospective Evaluations of the Syphilis Health Check Rapid Test Using Treponemal Tests as Reference Tests

		Treponemal Ref Test					Estimate (95% CI)
Author, Year, or Study Name From Regulatory Evaluation	Specimen Type	TP	TN	FP	FN	N	Sensitivity	Specificity
Clinical studies
Nakku-Joloba et al, 2016	Blood (not specified)	88	108	9	10	215	89.8% (82.0–95.0%)	92.3% (85.9–96.4%)
Matthias et al, 2016	Fingerstick,whole blood	10	172	16	4	202	71.4% (41.9–91.6%)	91.5% (86.6–95.1%)
Fakile et al, 2019	Fingerstick, whole blood	8	523	23	8	562	50.0% (24.7–75.4%)	95.8% (93.8–97.3%)
Fakile, Markowitz et al, 2019	Fingerstick, whole blood	13	930	6	13	962	50.0% (29.9–70.1%)	99.4% (98.6–99.8%)
Regulatory studies
CLIA study (package insert)a	Fingerstick, whole blood	197	208	6	4	415	98.0% (95.0–99.5%)	97.2% (94.0–99.0%)
FDA university clinic site	Serum	27	6	6	0	39	100.0% (87.2–100.0%)	50.0% (21.1–78.9%)
FDA hospital clinic site	Serum	6	44	0	0	50	100.0% (54.1–100.0%)	100.0% (92.0–100.0%)
FDA study site 1	Serum	21	365	8	6	400	77.8% (57.7–91.4%)	97.9% (95.8–99.1%)
FDA study site 2	Serum	4	85	0	0	89	100.0% (39.8–100.0%)	100.0% (95.8–100.0%)
FDA study site 3	Serum	9	193	2	1	205	90.0% (55.5–99.8%)	99.0% (96.3–99.9%)
Total	…	383	2634	76	46	3139	…	…
Pooled prospective (random-effects model)	…	…	…	…	…	…	87.7% (71.8–97.2%)	96.7% (91.9–99.2%)

DIC_fixed–DIC_random = 221.076–92.697.

Abbreviations: CI, confidence interval; CLIA, Clinical Laboratory Improvement Amendments; DIC, deviance information criterion; FDA, Food and Drug Administration; FN, false negative; FP, false positive; N, sample size; Ref, reference; TN, true negative; TP, true positive.

^aCLIA study used nontreponemal results in addition to the treponemal results in the patient infected status determination.